Cleared Traditional

K936058 - OPTODENT/OPTOGNATH

K936058 is an FDA 510(k) clearance for OPTODENT/OPTOGNATH, manufactured by Spectrum Healthcare Group. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K936058 · Spectrum Healthcare Group · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
147d
Days
Class 2
Risk

K936058 is an FDA 510(k) clearance for the OPTODENT/OPTOGNATH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Spectrum Healthcare Group (Fairburn, US). The FDA issued a Cleared decision on May 16, 1994 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectrum Healthcare Group devices

FDA 510(k) Submission Details - K936058

510(k) Number K936058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date May 16, 1994
Days to Decision 147 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 127d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELM Device Classification - Class 2, Special Controls

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELM Denture, Plastic, Teeth

All 17
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K936058.
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
K023035 · Ivoclar Vivadent, Inc. · Dec 2002
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
K962456 · Ivoclar North America, Inc. · Aug 1996
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
VITAPAN ACRYLIC DENTURE TEETH
K914476 · Vident · Mar 1992
DENTURE PLASTIC TEETH,76 ELM
K915276 · Nobelpharma USA, Inc. · Feb 1992